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Biomet --DCM AGC Molded Tibial Implant (12 mm x 80… recallZ-0076-2008 · Biomet, Inc. · initiated Jul 24, 2007

Terminated All recalls posted in October 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

FDA root cause category: Labeling mix-ups

What the company is doing

The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.

Recall details

Recall number
Z-0076-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 24, 2007
Posted by the FDA
Oct 31, 2007
Recalling firm
Biomet, Inc.
Quantity
4
Product code
JWH
FDA submissions
K921182
Distribution
Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.

Product description

Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.

Code information (models, lots, serial numbers)

Lot 311500; exp. 2012-02.

Other devices under the same FDA submission

15 devices cleared under K921182 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 44825).

Sources and updates

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